Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification (LOBACOM)
Primary Purpose
Chronic Low-back Pain
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
motion control fault tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Low-back Pain focused on measuring Low back pain, Movement control, Kinematic analysis, Clinical assessment
Eligibility Criteria
Inclusion Criteria:
- Aged more than 18 years
- Common low back pain (non-specific) with medical prescription
- Signed consent
Exclusion Criteria:
- Body Mass Index greater than 30 (obesity)
- Person who does not understand French
- Pregnant woman
- Refusal to participate
- Volunteer under guardianship or curatorship
Sites / Locations
- CHU de BrestRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
motion control fault testing
Arm Description
Each patient make six motion control fault tests in the same order : "waiters bow" "pelvic tilt" "one leg stance" "sitting knee extension" "rocking 4 point kneeling" "prone knee bend" This tests are performed three times.
Outcomes
Primary Outcome Measures
Range of compensation motion : "waiters bow" test
Lumbar flexion measured for test number 1 "waiters bow". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Range of compensation motion : "pelvic tilt" test
thoracic flexion measured for test number 2 "pelvic tilt". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "One leg stance" test
Pelvic shift measured for test number 3 "One leg stance ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "sitting knee extension" test
Lumbar flexion measured for test number 4 "sitting knee extension". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "rocking 4 point kneeling" test
Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "prone knee bend" test
Lumbar extension measured for test number 6 "prone knee bend". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Secondary Outcome Measures
Speed of execution for test 1
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 2
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 3
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 4
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 5
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 6
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Full Information
NCT ID
NCT05511012
First Posted
August 19, 2022
Last Updated
July 12, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT05511012
Brief Title
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification
Acronym
LOBACOM
Official Title
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.
Detailed Description
Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement control impairment". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.
LoBaCoM is a monocentric, exploratory prospective study.
The purpose is to define a kinematic (angular) threshold corresponding to an anomaly detected clinically by three therapists for each test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Low back pain, Movement control, Kinematic analysis, Clinical assessment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It is a prospective, monocentric, exploratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
motion control fault testing
Arm Type
Other
Arm Description
Each patient make six motion control fault tests in the same order :
"waiters bow"
"pelvic tilt"
"one leg stance"
"sitting knee extension"
"rocking 4 point kneeling"
"prone knee bend"
This tests are performed three times.
Intervention Type
Other
Intervention Name(s)
motion control fault tests
Intervention Description
Patients make 6 motion control fault tests, in the same order. Each test is performed three times
Primary Outcome Measure Information:
Title
Range of compensation motion : "waiters bow" test
Description
Lumbar flexion measured for test number 1 "waiters bow". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Time Frame
Day 0
Title
Range of compensation motion : "pelvic tilt" test
Description
thoracic flexion measured for test number 2 "pelvic tilt". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "One leg stance" test
Description
Pelvic shift measured for test number 3 "One leg stance ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "sitting knee extension" test
Description
Lumbar flexion measured for test number 4 "sitting knee extension". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "rocking 4 point kneeling" test
Description
Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "prone knee bend" test
Description
Lumbar extension measured for test number 6 "prone knee bend". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Speed of execution for test 1
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 2
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 3
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 4
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 5
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 6
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged more than 18 years
Common low back pain with medical prescription for rehabilitation
Signed consent
Be affiliated to a social security scheme
Be able to perform the lumbar motion control failure tests
Exclusion Criteria:
Body Mass Index greater than 30 (obesity)
Person who does not understand French
Pregnant woman
Refusal to participate
Volunteer under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent CREAC'H
Phone
+33(0)298017935
Email
vincent.creach@univ-brest.fr
Facility Information:
Facility Name
CHU de Brest
City
Brest
State/Province
Finistère
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent CREAC'H
Phone
+33(0)298017935
Email
vincent.creach@univ-brest.fr
First Name & Middle Initial & Last Name & Degree
Marine BOURHIS
First Name & Middle Initial & Last Name & Degree
Fanny GARGADENNEC
First Name & Middle Initial & Last Name & Degree
Thimothée HOUGRON
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
Learn more about this trial
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification
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